Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies:
Requirements of the international standard ISO 13485: 2018 Medical devices – Quality management systems – Requirements for regulatory purposes.
Requirements of the national standard DSTU EN ISO 13485: 2018 Medical devices. Quality management system. Regulatory requirements
The procedure for conducting audits of the QMS of companies producing medical devices.
Nikolay Matlaev, Lead Auditor of the Conformity Assessment Department of the Ukrainian Scientific Institute of Certification
The program of the event is available only on Ukrainian or RussianRead more
PharmaTechExpo Journal №3-4, 2020 The text of the article is available only in UkrainianRead more
Quality management // № 1-2 (49-50), January 2022 Guaranteeing the safety of products for consumers is a very important component of the image of cosmetics manufacturers. The leading motivation for the transition to work on GMP will be the standardization of production processes and the implementation of measures that make it possible to produce high-quality, […]Read more